Abstract
A clip for immobilizing leaflets of a cardiac or venous valve includes a hub having a pair of tangle resistant spring-biased outer arms coupled to an inferior end of the hub and a pair of tangle resistant spring-biased inner arms adjacent to the outer arms and coupled to a superior end of the hub. A delivery catheter may be used to position the valve clip adjacent a target valve while the outer and inner arms are biased in an opened position relative to each other. After the valve leaflets are located between the opened outer and inner arms, the biasing forces may be released to allow the clip to self-close the clip over the valve leaflets.
Claims
1. A valve clip comprising a hub configured to be removably attached to a deployment shaft; a first pair of leaf capture arms comprising a first inner arm and a first outer arm coupled to the hub; and a second pair of leaf capture arms comprising a second inner arm and a second outer arm coupled to the hub; wherein the outer and inner arms are configured to be biased apart to create a leaf capture space therebetween and to self-close over a valve leaflet when unbiased after the leaflet has been captured.
2. A valve clip as in claim 1, wherein at least some of the leaf capture arms are formed as a leaf spring with a resilient base attached to the hub and a less-resilient valve-grasping element extending from the base.
3. A valve clip as in claim 2, wherein the valve-grasping elements diverge from the base to form a V-shape when the outer and inner arms are unbiased.
4. A valve clip as in claim 3, wherein the base is curved and the valve-grasping element is straight the outer and inner arms pairs.
5. A valve clip as in claim 2, wherein the valve-grasping elements are parallel to a common axis when the outer and inner arms are unbiased.
6. A system for delivering a valve clip to heart or venous valve, said system comprising: a valve clip as in claim 1, and a deployment shaft configured to be removably attached to the hub of the valve clip.
7. A system as in claim 6, further comprising a steerable deployment catheter coupled to the deployment shaft.
8. A system as in claim 7, where an inferior end of the deployment shaft is configured to be coupled to the steerable deployment catheter.
9. A system as in claim 7, wherein a superior end of the deployment shaft is configured to be coupled to the steerable deployment catheter.
10. A system as in claim 6, wherein the steerable deployment catheter includes an imaging component.
11. A system as in claim 6, further comprising a first set of tethers positioned through the delivery catheter and coupled to the outer arms and configured to selectively bias the outer arms into a valve leaflet capture position.
12. A system as in claim 11, wherein the first set of tethers is further configured to selectively unbias the outer arms so that they self-close toward the valve leaflets.
13. A system as in claim 11, further comprising a second set of tethers positioned through the delivery catheter and coupled to the inner arms and configured to selectively bias the inner arms into a valve leaflet capture position.
14. A system as in claim 13, wherein the second set of tethers is further configured to selectively unbias the inner arms so that they self-close toward the valve leaflets.
15. A system as in claim 11, further comprising a first set of tethers positioned through the delivery catheter and coupled to the outer arms and configured to selectively bias the outer arms into a valve leaflet capture position and a second set of tethers positioned through the delivery catheter and coupled to the inner arms and configured to selectively bias the inner arms into a valve leaflet capture position.
16. A system as in claim 11, further comprising a pair of posts reciprocatably coupled to the deployment shaft, wherein the posts engage at least the two lower arms or the two upper arms to selectively open the lower and upper arms into a valve leaflet capture position, wherein the posts are configured to engage an upper surface of each outer arm, wherein advancing the posts in an inferior direction opens the outer arms relative to the inner arms.
17. A system as in claim 16, wherein inner arms are configured to remain stationary as the posts are advanced, wherein the posts are configured to engage a lower surface of each inner arm, wherein advancing the posts in a superior direction opens the inner arms relative to the outer arms, and wherein outer arms are configured to remain stationary as the posts are advanced.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0109] FIG. 1A-1 illustrates the left ventricle and left atrium of the human heart during systole.
[0110] FIG. 1A-2 illustrates the free edges of mitral valve leaflets in normal coaptation.
[0111] FIG. 1A-3 illustrates the free edges of mitral valve leaflets in regurgitative coaptation.
[0112] FIG. 1B-1 illustrates the fixation device mounted in a retrograde orientation relative to the leaflets.
[0113] FIG. 1B-2 illustrates the fixation device mounted in a preferred antegrade orientation relative to the leaflets.
[0114] FIGS. 2A through 2H depict various embodiments of the catheter-based delivery system used to deploy the fixation device within the heart.
[0115] FIGS. 2I-1 and 2I-2 illustrate distal segment of the introducer sheath when manipulated in a two-way steerable configuration.
[0116] FIGS. 2J through 2P and 2Q-1 through 2Q-3 depict a preferred embodiment of the exemplary 12 Fr catheter based delivery system used to deploy the fixation device within the heart.
[0117] FIGS. 3A, 3B-1, 3B-2, and 3C show various exemplary embodiments of the fixation device.
[0118] FIG. 4A through 4F depict a step-by-step deployment of the preferred embodiment using simultaneous leaflet capture.
[0119] FIG. 5A through 5D depict the step-by-step capture of the mitral valve leaflet using side-by-side capture via independent manipulation of the inner arms.
[0120] FIG. 6A through 6D depict the step-by-step capture of the mitral valve leaflet using side-by-side capture via independent manipulation of the inner and outer arms.
[0121] FIG. 7A through 7F depict the step-by-step bailout procedure after any extent of leaflet capture by the arms.
[0122] FIG. 8A illustrates the mechanism by which the outer arms are manipulated.
[0123] FIG. 8B is a detailed illustration of the mechanism of FIG. 8B.
[0124] FIG. 8C illustrates an intermediate position of the mechanism of FIGS. 8A and 8B for controlling the outer arms during bailout. This position of the sutures is beneficial ejecting the mitral valve leaflets from the device.
[0125] FIG. 8D is a detailed view of the mechanism of FIG. 8C.
[0126] FIG. 9A illustrates a mechanism for manipulating the inner arms.
[0127] FIG. 9B is a detailed view of the mechanism of FIG. 9A.
[0128] FIG. 9C shows an alternative embodiment of a mechanism for manipulating the inner arms.
[0129] FIG. 9D shows the mechanism of FIG. 9C with the inner arms in a collapsed state.
[0130] FIG. 10A illustrates another embodiment of the clip and deployment mechanism for controlling both the inner and outer arms.
[0131] FIG. 10B is a detailed illustration of the deployment mechanism of FIG. 10A, with retraction of a release rod.
[0132] FIG. 10C depicts the release of a valve clip using the release rod of FIG. 10B.
[0133] FIG. 10D is a detailed view of the release mechanism pictured in FIG. 10C.
[0134] FIG. 10E depicts retraction of the delivery system after release of the valve clip.
[0135] FIGS. 11 and 11A-11D illustrate a specific fixation device (valve clip) embodiment, with isolated views of the inner and outer arms.
[0136] FIGS. 12 and 12A-12D illustrate a further embodiment of a valve clip fixation device in which opposed arms have dissimilar lengths with isolated views of the inner and outer arms.
[0137] FIG. 12E illustrates the valve clip of FIG. 12 implanted in a mitral valve.
[0138] FIG. 13A illustrates a further embodiment of a valve clip fixation device in which the inner and outer arms are formed by single parts.
[0139] FIG. 13B illustrates a further embodiment of a valve clip fixation device having a spacer in the base.
[0140] FIG. 13C illustrates a further embodiment of the fixation device which utilizes two arms.
[0141] FIG. 13D illustrates a further embodiment of the fixation device in which utilizes four arms along the coapting length of the native leaflet.
[0142] FIG. 13E illustrates an exemplary embodiment with three pairs of inner and outer arms. This to capture separate 3 leaflets, for example, in a tricuspid valve.
[0143] FIGS. 13F-1 and 13F-2 illustrate a further embodiment of the base bracket 10 with a contoured feature that allows for easier detachment of the fixation device from the delivery catheter.
[0144] FIG. 13G-1 through 13K-2 illustrate a further embodiment of the Release Bar 16 with a post feature that allows for spreading of the outer arms of the fixation device during deployment.
[0145] FIG. 14 illustrates further embodiment configurations of the fixation device in which arms of either side are of different lengths.
[0146] FIG. 15 illustrates further embodiment configurations of the fixation device in which arms of either side are of different angles.
[0147] FIG. 16. illustrates further embodiment configurations of the fixation device in which arms of either side are of different angles at shape-set or unconstrained angles.
[0148] FIG. 17A reproduces a MitraClip® embodiment (FIG. 11B, U.S. Pat. No. 8,057,493 B2; page 8 of 68), showing inner gripping arms with exposed barbs 60 on the sides.
[0149] FIG. 17B illustrates an improvement upon the Mitraclip® device in which the barbs 60 have been repositioned within the width of the arms 60′, in lines with the tangle-resistant aspects of this invention.
[0150] FIG. 18A through 18E illustrate further embodiments of the fixation device which utilizes a camera/optic system with various styles of viewing balloons to provide a visual during deployment.
[0151] FIG. 19 illustrates a further embodiment of the fixation device which utilizes OCT sensors to provide a visual during deployment.
[0152] FIG. 20 illustrates a further embodiment of the fixation device which utilizes ultrasound echography sensors to provide a visual during deployment.
DETAILED DESCRIPTION OF THE INVENTION
I. Cardiac Physiology
[0153] The left ventricle LV of a normal heart H in systole is illustrated in FIG. 1A-1. The left ventricle LV is contracting and blood flows outwardly through the tricuspid (aortic) valve AV in the direction of the arrows. Back flow of blood or “regurgitation” through the mitral valve MV is prevented since the mitral valve is configured as a “check valve” which prevents back flow when pressure in the left ventricle is higher than that in the left atrium LA. The mitral valve MV comprises a pair of leaflets having free edges FE which meet evenly to close, as illustrated in FIG. 1A-1. The opposite ends of the leaflets LF are attached to the surrounding heart structure along an annular region referred to as the annulus AN. The free edges FE of the leaflets LF are secured to the lower portions of the left ventricle LV through chordae tendineae CT (referred to hereinafter as the chordae) which include plurality of branching tendons secured over the lower surfaces of each of the valve leaflets LF. The chordae CT in turn, are attached to the papillary muscles PM which extend upwardly from the lower portions of the left ventricle and intraventricular septum IVS.
[0154] A number of structural defects in the heart can cause mitral valve regurgitation. Regurgitation occurs when the valve leaflets do not close properly allowing leakage from the ventricle into the atrium. As shown in FIG. 1A-2, the free edges of the anterior and posterior leaflets normally meet along a line of coaptation C. An example of a defect causing regurgitation is shown in FIG. 1A-3. Here an enlargement of the heart causes the mitral annulus to become enlarged, making it impossible for the free edges FE to meet during systole. This results in a gap G which allows blood to leak through the valve during ventricular systole. Ruptured or elongated chordae can also cause a valve leaflet to prolapse since inadequate tension is transmitted to the leaflet via the chordae. While the other leaflet maintains a normal profile, the two valve leaflets do not properly meet and leakage from the left ventricle into the left atrium will occur. Such regurgitation can also occur in patients who have suffered ischemic heart disease where the left ventricle does not contract sufficiently to effect proper closure.
II. General Overview
[0155] The present invention provides methods and devices for grasping, approximating and fixating tissues such as valve leaflets to treat cardiac valve regurgitation, particularly mitral valve regurgitation. The present invention also provides features that allow repositioning and removal of the device if so desired, particularly in areas where removal may be hindered by anatomical features such as chordae CT. Such removal would allow the surgeon to re-approach the valve in a new manner if so desired.
[0156] Grasping will preferably be atraumatic providing a number of benefits. By atraumatic, it is meant that the devices and methods of the invention may be applied to the valve leaflets and then removed without causing any significant clinical impairment of leaflet structure or function. The leaflets and valve continue to function substantially the same as before the invention was applied. Thus, some minor penetration or denting of the leaflets may occur using the invention while still meeting the definition of “atraumatic”. This enables the devices of the invention to be applied to a diseased valve and, if desired, removed or repositioned without having negatively affected valve function. In addition, it will be understood that in some cases it may be necessary or desirable to pierce or otherwise permanently affect the leaflets during either grasping, fixing or both. In some of these cases, grasping and fixation may be accomplished by a single device. Although a number of embodiments are provided to achieve these results, a general overview of the basic features will be presented herein. Such features are not intended to limit the scope of the invention and are presented with the aim of providing a basis for descriptions of individual embodiments presented later in the application.
[0157] The devices and methods of the invention rely upon the use of an interventional tool that is positioned near a desired treatment site and used to grasp the target tissue. In endovascular applications, the interventional tool is typically an interventional catheter. In surgical applications, the interventional tool is typically an interventional instrument. In preferred embodiments, fixation of the grasped tissue is accomplished by maintaining grasping with a portion of the interventional tool which is left behind as an implant. While the invention may have a variety of applications for tissue approximation and fixation throughout the body, it is particularly well adapted for the repair of valves, especially cardiac valves such as the mitral valve and tricuspid valve.
[0158] FIGS. 1B-1 and 1B-2 illustrate the fixation device in both retrograde and antegrade configurations respectfully for deployment. The fixation device is attached to the Release bar 16 or 166 which are part of the distal delivery catheter 499. In both surgical methods, the placement and position of the device remains unchanged. This may allow the fixation device to be deployed using various entry points that best suit the user need. For illustration purposes, an antegrade approach will be primarily described going forward.
[0159] FIGS. 2A through 2H depict various embodiments of the catheter-based fixation device delivery system that may be used to deploy the fixation device. Knobs 502 and 503 are used to reposition the inner (14, 22) and outer (12, 20) arms of the fixation device to (14′, 22′) and (12′, 20′) respectively and vice-versa, in order to secure the two leaflets LF (arm manipulation). Each knob may be configured to manipulate either the outer or inner arms of the device. Although only two handles systems have been exemplified, this concept may be extended to include three or more handle systems having a combination of fixed and/or steerable shaft systems.
[0160] FIG. 2A illustrates one embodiment of the delivery system utilizing a fixed curve introducer sheath in combination with four-way steerable delivery catheter. The arm manipulation knobs 502 and 503 are configured on the same catheter handle 508. Knobs 500 and 501 are used to steer the distal delivery shaft 499 of the catheter in four directions; each knob (500 and 501) provides two-way steering. The distal introducer sheath 498 holds a fixed curve.
[0161] FIG. 2B illustrates a further embodiment of the delivery system utilizing a fixed curve introducer sheath in combination with two-way steerable delivery catheter. The arm manipulation knobs 502 and 503 are configured similar to catheter handle 508. Knob 504 is used to direct the distal delivery shaft 499 of the catheter in two directions to provide two-way steering. The distal introducer sheath 498 holds a fixed curve.
[0162] FIG. 2C illustrates a further embodiment of the delivery system utilizing a two-way steerable introducer sheath in combination with delivery catheter. The introducer sheath handle 510 houses a two-way steering knob 505 in order to manipulate and steer the distal sheath 498. This is placed in tandem with another handle 511, which in turn holds the arm manipulation knobs 502 and 503. Note, off-the shelf two-way steerable introducer sheath from Merit Medical (HeartSpan® Steerable Sheath Introducer, https://www.merit.com/cardiac-intervention/ep-and-crm/electrophysiology/heartspan-steerable-sheath-introduced) is shown for the purpose of illustration and as an example.
[0163] FIG. 2D illustrates a similar embodiment of the delivery system utilizing a four-way steerable introducer sheath in combination with delivery catheter. The introducer sheath handle 510 houses two 2-way steering knobs 506 and 507 in order to manipulate and steer the distal sheath 498 to provide four-way steerablility. This is placed in tandem with another handle 511, which in turn holds the arm manipulation knobs 502 and 503.
[0164] FIG. 2E illustrates a further embodiment of the delivery system utilizing a two-way steerable guide catheter in combination with a two-way steerable delivery catheter. The introducer sheath handle 510 houses a two-way steering knob 505 in order to manipulate and steer the distal sheath 498. This is placed in tandem with another handle 515, which in turn holds the arm manipulation knobs 502, 503 and additionally, knob 518 that provides two-way steering of distal delivery shaft 499. Note, an off-the-shelf two-way steerable introducer sheath from Merit Medical (HeartSpan® Steerable Sheath Introducer, (https://www.merit.com/cardiac-intervention/ep-and-crm/electrophysiology/heartspan-steerable-sheath-introduced) is shown for the purpose of illustration and as an example.
[0165] FIG. 2F illustrates a further embodiment of the delivery system utilizing a two-way steerable guide catheter in combination with a four-way steerable delivery catheter. The introducer sheath handle 510 houses a two-way steering knob 505 in order to manipulate and steer the distal sheath 498. This is placed in tandem with another handle 517, which in turn holds the arm manipulation knobs 502, 503; and additionally knobs 520 and 521 that each provide two-way steering of distal delivery shaft 499 that results in four-way steerablility. Note, an off-the shelf two-way steerable introducer sheath from Merit Medical (HeartSpan® Steerable Sheath Introducer, (https://www.merit.com/cardiac-intervention/ep-and-crm/electrophysiology/heartspan-steerable-sheath-introduced) is shown for the purpose of illustration and as an example.
[0166] FIG. 2G illustrates a further embodiment of the delivery system utilizing a four-way steerable guide catheter in combination with a two-way steerable delivery catheter. The steerable guide catheter handle 523 houses two 2-way steering knobs 529 and 528 in order to manipulate and four-way steer the distal sheath 498. This is placed in tandem with another handle 515, which in turn holds the arm manipulation knobs 502, 503 and additionally, knob 518 that provides two-way steering of distal delivery shaft 499. In some embodiments, the knob 518 may be configured for arm manipulation in lieu of delivery catheter steerablility.
[0167] FIG. 2H illustrates a further embodiment of the delivery system utilizing a four-way steerable introducer sheath in combination with a two-way steerable delivery catheter. The introducer sheath handle 523 houses 2 two-way steering knobs 529 and 528 in order to manipulate and four-way steer the distal sheath 498. This is placed in tandem with another handle 517, which in turn holds the arm manipulation knobs 502, 503; and additionally knobs 520 and 521 that each provide two-way steering of distal delivery shaft 499 resulting in four-way steerablility.
[0168] FIGS. 2I-1 and 2I-2 illustrate the movement of the distal introducer sheath 498 with two-way steering configuration.
[0169] FIGS. 2J through 2Q depict a preferred embodiment of an exemplary 12 Fr custom catheter based delivery system used to deploy the fixation device within the heart.
[0170] FIG. 2J illustrates a further embodiment of the exemplary 12 Fr delivery system utilizing a four-way steerable guide catheter in combination with a delivery catheter, similar to FIG. 2G, however, using custom handles 745, 747. The steerable guide catheter handle 745 houses two 2-way steering knobs 529 and 528 in order to four-way steer the sheath 498. The steerable guide is placed in tandem with delivery catheter handle 747, which in turn holds the arm manipulation knobs 502, 503 and additionally, knob 518 that is configured for arm manipulation in lieu of delivery catheter steerablility. In a preferred embodiment, Knobs 502 is used to independently manipulate one inner arm, while the Knob 503 is used to independently manipulate the other inner arm. The third knob 518 is used to manipulate the two outer arms simultaneously.
[0171] FIG. 2K shows the distal segments of the catheter system shown in FIG. 2J. As can be seen, the exemplary 9 Fr outer diameter delivery catheter shaft 499 passes through the lumen of the exemplary 12 Fr inner diameter steerable guide catheter shaft 498.
[0172] FIG. 2L shows the steerable guide and delivery catheter handles side-by-side. The exemplary stainless-steel tube 623 provides a means to support and attach the steerable guide catheter handle on to a suitable stand (not shown). While, the exemplary stainless-steel tube 615 provides a means to support and translate the delivery catheter, when inside the steerable guide handle.
[0173] FIG. 2M shows detailed view of the delivery catheter handle with a flush port 715, which can optionally be used to measure hemodynamic pressure at the Release bar 16. In addition, figure shows exemplary quarter turn locking Release rod knob 550. The knob 550 can be used to manipulate the Release Rod 18 and thereby release/deploy the fixation element.
[0174] FIG. 2N shows exemplary distal segment of the custom delivery catheter.
[0175] FIG. 2O shows details of the steerable guide handle 745 with dilator proximal shaft 403 and quarter turn locking dilator knob 730. In addition, the Steerable guide catheter handle consists of a lockable and pinchable hemostasis valve 735. When unlocked and not pinched by the user, the hemostasis valve collapses to tightly close on itself to provide hemostasis seal. If a dilator 403 (or delivery catheter) is present, it will then close on to the dilator 403 (or delivery catheter), wherein, in addition to providing hemostasis seal, it also constrains the motion of the dilator 403 (or delivery catheter), as shown in FIG. 2O.
[0176] When locked using the lock 727 as shown in FIG. 2P or when pinched by user, the hemostasis valve opens to allow for free movement or passage of the dilator (or delivery catheter). The optional and exemplary labels 700 and 702 show steerability functions of the knobs 520 and 528.
[0177] FIG. 2Q-1 shows the detailed view of the distal segment of the steerable guide catheter shaft 498. The shaft 498 is wire reinforced to provide the required kink resistance, torquability and pushability. The proximal shaft 405 is relatively stiff, while the distal steerable shaft 402 is relatively flexible and the intermediate shaft 401 provides a mid-level blending stiffness. To enhance visualization under fluoroscopy, there are 3 radio-opaque markers 400.
[0178] FIG. 2Q-2 shows one of the exemplary label 702. Manipulation of the corresponding knob (528, as shown in FIGS. 2O, 2P), results in exemplary steering of distal segments 402, 401 of the steerable guide catheter shaft 498.
[0179] FIGS. 3A through 3C show exemplary prototypes of the fixation device types.
[0180] FIG. 3A shows the first barebone prototype, where the inner and outer arms are fastened using sutures and pin. Further, in this exemplary prototype, the inner and outer arms are contoured to allow additional grasp beyond the required coaptation of the native valve. The inner and outer arms of this exemplary prototype were made of nitinol.
[0181] FIG. 3B-1 shows yet another exemplary embodiment of the contoured fixation device. As can be seen, this is a complete prototype of the fixation device (with inner arms 14, 22, outer arms 12, 20, base bracket 10 and fastener 24. The inner and outer arms of this exemplary prototype are made of nitinol, while, the base bracket 10 and fastener 24 are made of titanium.
[0182] FIG. 3B-2 shows individual inner arms 14, 22 and outer arms 12, 20, of the fixation device shown in FIG. 3B-1. Note that the outer arms of FIGS. 3B-1 and 3B-2 have fewer barbs or frictional elements when compared to outer arms of the prototype shown in FIG. 3A or 3C.
[0183] FIG. 3C shows yet another exemplary embodiment of the contoured fixation device. As can be seen, this is a complete prototype of the fixation device (with inner arms 14, 22, outer arms 12, 20, base bracket 10 and fastener 24. The inner and outer arms of this exemplary prototype are made of nitinol, while, the base bracket 10 and fastener 24 are made of titanium. In comparison to contoured prototypes of fixation devices in FIGS. 3A and 3B-1, this prototype is designed primarily for the coapting region of the native valve.
[0184] FIGS. 4A-4F depict arm manipulation to be controlled by, for example knobs 502, 503 and/or 518. Specifically, these figures illustrate the preferred step-by-step deployment of the fixation device in antegrade orientation.
[0185] Before insertion of the device and delivery assembly through the mitral valve, the device remains in a collapsed state inside the steerable guide catheter shaft 498, wherein, all arms are folded upward. This is illustrated in FIG. 4A by the position of the arms 12, 20, 14, 22.
[0186] FIG. 4A shows the manipulations 60 and 61 of outer arms 12 and 20 to positions 12′ and 20′ after insertion of the device past the mitral valve leaflets LF.
[0187] FIG. 4B further illustrates this by showing the final position of the outer arms 12 and 20 facing up underneath the valve leaflets LF.
[0188] FIG. 4C shows the repositioning of the fixation device such that the mitral valve leaflets LF are secured by the outer arms 20 and 12. This is achieved by translating the device ˜1 cm towards the atrial direction.
[0189] FIG. 4D shows the capture of the leaflets LF by the 62 and 63 movement of arms 14 and 22 to positions 14′ and 22′. The barbed features of said elements secure the leaflets LF to the fixation device.
[0190] FIG. 4E further illustrates the end product of capture, in which the arms 14, 22, 12, and 20 have effectively captured the leaflets LF of the mitral valve.
[0191] FIG. 4F shows the deployed state of the fixation device. Note that FIG. 4F is the end state of all the described procedures for deployment of the preferred embodiment.
[0192] FIGS. 5A-5D depict arm manipulation to be controlled by, for example knobs 502, 503 and/or 518. Specifically, these figures illustrate a step-by-step deployment of the fixation device in an antegrade orientation, in which the each of the inner arms 22 and 14 capture leaflets independently.
[0193] FIG. 5A illustrates the preferred embodiment after its placement underneath the mitral valve leaflets LF, as explained previously in FIG. 4C.
[0194] FIG. 5B depicts the independent manipulation 62 to drop inner arm 22 to the position 22′, capturing the first leaflet LF.
[0195] FIG. 5C illustrates the proceeding position of the manipulation 62.
[0196] FIG. 5D depicts the independent manipulation 63 of the second inner arm 14 to the position 14′, capturing the second leaflet LF. Note that the order of manipulations 62 and 63 are interchangeable to meet the preferred used need.
[0197] FIGS. 6A-6D depict alternate variant of independent arm manipulations to sequentially capture the leaflets LF. Specifically, these figures illustrate a step-by-step deployment of the fixation device in an antegrade orientation for the purposes of representation of the idea.
[0198] FIG. 6A illustrates the manipulation 60 of outer arm 20 to position 20′. The device must now be positioned such that the leaflet LF apposes the barbed features of arm 20.
[0199] FIG. 6B shows the capture of the leaflet LF by the dropping 62 of inner arm 22 to position 22′. This captures the first leaflet LF.
[0200] The product of manipulation 60 followed by manipulation 62 is shown in FIG. 6C, in which the device has successfully captured one leaflet LF. It also shows the manipulation 61 to reposition the outer arm 12 to position 12′.
[0201] FIG. 6D illustrates the manipulation 63, which drops the inner arm 14 to position 14′ in order to capture the second leaflet LF.
[0202] Note that the manipulation pairs (60, 62) and (61, 63) may be interchanged in order to meet the user need.
[0203] The product of the manipulations depicted in FIGS. 6A-6D is illustrated in FIG. 4E, in which the arms 14, 22, 12, and 20 have effectively captured the leaflets LF of the mitral valve.
[0204] The preferred embodiment is designed to allow for the user to abort the device deployment following any complication. Further, bailout procedure may be needed in order to correct or reposition suboptimal capture of leaflets. An example of the “bailout” procedure is illustrated in FIGS. 7A-7F.
[0205] FIG. 7A shows the exemplary fixation device after complete capture of the mitral valve leaflets LF.
[0206] FIG. 7B shows the release of the leaflets LF by lifting the inner capture arms 22 and 14 to positions 22′ and 14′ via manipulations 64 and 65. FIG. 7C depicts the end result of manipulations 64 and 65. FIG. 7D illustrates the actuations 51 and 52 of sutures 47 and 48, such that suture segments 42 and 44 are translated to positions 42′ and 44′. Note that this translation lifts the leaflets LF off of the outer arms 12 and 20 to the positions LF′. FIG. 7E shows the end result of these manipulations 51 and 52. FIG. 7F shows the further embodiment of manipulations 51 and 52, in which the arms 20 and 12 are fully collapsed upward. At this stage, the bailout is complete and the fixation device can be retracted away from the mitral valve into the atrium. The user may choose to re-attempt the procedure or fully retract and remove the fixation device and delivery catheter 499 through the steerable guide catheter shaft 498.
[0207] FIGS. 8A-8D give a more detailed depiction of the fixation device's movements and manipulations focusing on the sutures, which connect the fixation device to the delivery system.
[0208] FIG. 8A illustrates the backside of the device (facing component 16) without showing inner arms 14 and 22 to avoid cluttering of the illustration. This depiction represents the position of all other device elements whilst the outer arms 12 and 20 are ready for capture. Suture 95 travels down the catheter tube and elements 28 and 16, then through loop 98 and forms segments 91 and 93. Suture 97 travels down the catheter tube and elements 28 and 16 and forms segments 92 and 94. The distal ends of sutures 91 and 92 are looped to the release rod 18 through the hole 30. Suture 96 also travels down the catheter tube and the front side of elements 28 and 16, which in turn travels through feature 30 to be looped through loop 98. FIG. 8B is a zoomed-in image of FIG. 8A, designated by the circle drawn around feature 30. Note that the use of a loop 98 can be rendered moot by utilizing the loop at the distal end of suture 96.
[0209] FIG. 8C represents a further embodiment of the illustration within FIG. 8A. Here, the manipulations 110, 111, and 112 translate the suture segments 93, 94, and 98 from their original positions held in FIG. 8A. Note that manipulations 110 and 112 can be via knobs on the handle (for example Knob 518), while, this ejects the leaflets LF from their positions on the outer arms 12 and 20, allowing for bailout. FIG. 8C is essentially a more detailed illustration of the preferred embodiment in FIG. 7E. FIG. 8D offers a zoomed image of the embodiment in FIG. 8C, designated by the black circle drawn around element 30. Note that in a preferred exemplary embodiment, manipulations 110 and 112 can be active manipulations of knobs on the delivery handle (for example simultaneous pull on both 110 and 112 using a single Knob 518) while, the manipulation 111 can be passive (for example exerting a constant tension using a spring).
[0210] FIGS. 9A through 9D offer a more detailed view of the mechanisms that manipulate the inner arms 14 and 22. Note that the sutures and mechanisms involving the outer arms 12 and 20 are not displayed in FIG. 9A through 9D for simplicity.
[0211] FIG. 9A illustrates the fixation device prior to the manipulations 77 and 78 act on sutures 75 and 76 in order to collapse the inner arms 14 and 22. Note that suture 76 is also comprised of segments 74 and 72. Similarly, suture 75 is comprised of segments 73 and 71. The distal ends of segments 71 and 72 are looped around the release rod 18 through feature 26 on the deployment bar 16. FIG. 9B offers a closer view of the mechanisms and sutures described above, designated by the circle drawn around feature 26. FIG. 9C depicts a further embodiment of the fixation device, wherein the suture segments 71 and 73 loop via a separate suture loop 83 that is attached to the inner arm 14. Similarly, suture segments 72 and 74 loop via a separate suture loop 82. the sutures loops through loops 83 and 82. FIG. 9D shows the fixation device, wherein, continuation of manipulations 77 and 78 have successfully collapsed the inner arms 14 and 22. This is essential in the bailout procedure, as it allows the device to be compacted for retraction. In addition, this manipulation for raising and lowering of the inner arms, while keeping the outer arms are lowered, allows the user to make several attempts to capture the leaflets.
[0212] FIGS. 10A through 10E illustrate the deployment and separation of the fixation device from the delivery system.
[0213] FIG. 10A depicts the fixation device in its end position after capturing the mitral valve leaflets LF (NOT SHOWN). FIG. 10B is a zoomed image of a circular portion of FIG. 10A, designated by the circle drawn around element 30. Here, manipulation 180 acts on the release rod 18 as it is pulled from the delivery system, for example, using the release rod knob 550. The result of this manipulation is shown in FIG. 10C, where the fixation device has been effectively separated from the deployment bar 16. FIG. 10D depicts the effect of manipulation 180 on the suture segments 91 and 92: they are unlinked from the device due to the removal of the release rod 18 and retracted along their lengths up through the delivery system. Note that the release of suture segments 71 and 72 occurs through the same mechanism through feature 26. The end product of the release can be viewed in FIG. 10E, in which the device has successfully been implanted within the heart and the distal delivery system is ready for retraction.
[0214] FIG. 11 shows an example of embodiment with inner (22, 14) and outer (12, 20) arms post shape-set, outside of the fixation device. Additionally, it shows the flat pattern of the inner (22″, 14″) and outer (12″, 20″) arms to illustrate one method of manufacturing the arms using laser or wire EDM cut nitinol flats.
[0215] FIG. 12 shows an example of preferred embodiment with inner (22, 122) and outer (120, 20) arms post shape-set, outside of the fixation device. Note that the inner 122 and outer 120 arms are shorter than 22 and 20, to accommodate shorter posterior mitral valve leaflets. Additionally, it shows the flat pattern of the inner (122″) and outer (120″) arms to illustrate one method of manufacturing the arms using laser or wire EDM cut nitinol flats.
[0216] FIG. 13A through 13E illustrate various alternate embodiments of the fixation device. Note that any combination of these embodiments and previously discussed embodiments may be used to address the desired user need.
[0217] FIG. 13A illustrates an embodiment wherein, both outer arms are formed as a single, continuous bifurcated outer arm component 201 that grasps the leaflet on either side. Similarly, both inner arms are formed as a single, continuous bifurcated inner arm component 202 that grasps the leaflet on either side.
[0218] FIG. 13B shows an example of embodiment of the fixation device wherein there a spacer 203 in between the inner arms. This spacer provides a) provide space for thicker leaflets LF, b) provide additional flexibility to the inner arms, and c) provide an alternate site to detachably couple the fixation device with the delivery catheter.
[0219] FIG. 13C illustrates an example of a valve clip fixation device embodiment having only two outer arms 204 and no inner arms, designed to capture the leaflets LF. Additionally, FIG. 13C shows an example of embodiment of the fixation device wherein there is a spacer 203 in between the arms. This spacer may be used to provide gap for tissue capture or for attachment of the fixation device to the delivery catheter.
[0220] FIG. 13D illustrates a valve clip fixation device embodiment using a pair of outer arms 136, 132 and inner arms 134, 138, to capture the leaflets LF, primarily along a line of caption 205 of the native valve. In contrast to previous embodiments where the capture arms diverge from the line of coaptation when grasping the leaflets, the capture arms of FIGS. 13C and 13D are aligned in parallel with the line of coaptation when grasping the leaflets.
[0221] FIG. 13E shows an embodiment of a valve clip fixation device wherein there are three pairs of inner and outer arms 206. This, to grasp three sets of leaflets such as a tricuspid valve.
[0222] FIGS. 13F-1 and 13F-2 show an exemplary embodiment of base bracket 10 with a slanting feature 11 which enhances the ease of detachment of the fixation device up on removal of release rod 18 during deployment.
[0223] FIGS. 13G-1 through 13G-4 show an exemplary embodiment of a release bar 16, with two posts 17. The posts aid in spreading (or lowering) of the outer arms during capture of the leaflets while allowing for seamless detachment from the fixation device during deployment.
[0224] FIGS. 13H-1 and 13H-2 illustrate the function of the posts 17. FIGS. 13H-1 and 13H-2 show the back and side view of the release bar 16, respectively, and base bracket 10 and release rod 18 subassembly. Note, the arms are not shown for clarity. In the start position, the base bracket 10 is at a lower position and there is a gap 54 between the posts 17 and base bracket 10.
[0225] In FIGS. 13I-1 and 13I-2, the base bracket is manipulated towards the post 17, using, for example wire or sutures connected to one of the delivery catheter handle knobs. This manipulation results in reduction of the gap 54.
[0226] FIGS. 13J-1 and 13K-2 show the a portion of the front view of the release bar 16, release rod 18, and schematics of outer arms 132, 136 and inner arms 134, 136. FIG. 13J-1 shows the base bracket 10 in start position. In this exemplary embodiment, the inner and outer arms are typically made of a superelastic material such as nitinol. The outer arms are shape-set towards a vertical position while the inner arms are shape-set towards the horizontal position. Thus, there is a constant bias for the outer arms to move towards the vertical position as in FIG. 13D, while the inner arms are constantly biased towards the outer arms. Further, the outer arms are made stronger in comparison to inner arms, for example by using thicker outer arms. Further, the inner arms are positioned in a raised position using previously described techniques, for example in FIG. 9D. Therefore, the outer arms are constrained only by the posts 17. In FIG. 13J-2, the base bracket 10 is manipulated upwards towards the posts 17. This results in the desired lowering of the outer arms, as they are pushed down against the posts 17.
[0227] FIGS. 13K-1 and 13K-2 are similar to FIGS. 13J-1 and 13J-2, with the inner arms 134, 138 pre-set to be in a lowered position.
[0228] Although in FIGS. 13G-1 through 13K-2 show posts that are fixed to the Release bar 16, it will be obvious to those skilled in art to make the posts movable. For example, the posts may be mounted on a lever arm and hinged to the release bar 16 and be used to manipulate the arms with a mechanical advantage using tethers.
[0229] FIG. 14 shows an example of an embodiment wherein the outers arms do not have barbs or frictional elements. Alternatively, the inner arms may or may not have barbs or fictional elements. Further, the length of each individual inner or outer arm may vary such that:
[0230] Offset lengths A=0 to 100 mm, B=0 to 100 mm; C=0 to 100 mm, D=0 to 100 mm; and A≥B; or B≥A; or B≠A; C≥D; or D≥C; or C≠D; B≥D; or D≥B; or B≠D; A≥C; or C≥A; or C≠A. Note, that although only the offset lengths were depicted, the same may be applied to individual physical length of the entire arm or to just the section of the arm that engages with the leaflets. That is, each individual arm may be of different size in thickness, length and width.
[0231] FIG. 15 illustrates various configuration of the fixation device embodiments, such that the final angle (Af, Bf, Cf, Df)=0 to 180 degrees; and Angle Af≥Angle Bf; or Angle Af≤Angle Bf; or Angle Af≠Angle Bf; Angle Cf≥Angle Df; or Angle Cf≤Angle Df; or Angle Cf≠Angle Df; Angle Af≥Angle Cf; or Angle Af≤Angle Cf; or Angle Af≠Angle Cf; Angle Bf≥Angle Df; or Angle Bf≤Angle Df; or Angle Bf≠Angle Df Note, in a preferred configuration, the inner and outer arms are elastically or super-elastically biased towards each other with sufficient force, so as to securely capture the leaflets when place between them.
[0232] FIG. 16 illustrates various configuration of the fixation device embodiments, such that the final angle (As, Bs, Cs, Ds)=0 to 180 degrees; and Angle As≥Angle Bs; or Angle As≤Angle Bs; or Angle As≠Angle Bs; Angle Cs≥Angle Ds; or Angle Cs≤Angle Ds; or Angle Cs≠Angle Ds; Angle As≥Angle Cs; or Angle As≤Angle Cs; or Angle As≠Angle Cs; Angle Bs≥Angle Ds; or Angle Bs≤Angle Ds; or Angle Bs≠Angle Ds. Note that in a preferred embodiment, final and shape-set angles may have the following relationship: Angle Af≤Angle As; Angle Bf≤Angle Bs; Angle Cs≤Angle Cf; Angle Df≤Angle Ds; Angle As≠Angle Bf; Angle Cs≠Angle Ds.
[0233] FIG. 17A reproduces a MitraClip® embodiment (FIG. 11B, U.S. Pat. No. 8,057,493 B2; page 8 of 68), showing inner gripping arms with exposed barbs 60 on the sides.
[0234] FIG. 17B depicts a further embodiment of this invention, wherein the MitraClip® external barbs 60 in FIG. 17A have been replaced and redesigned with internal barbs 60′ (FIG. 17B), in-line with current invention. In this invention, designing the arms such that the barbs are within the arms rather than on the exterior of the arms further ensures that chordae, tissue or delivery device components (for example sutures or wires) are not un-intentionally or accidentally caught, tangled or be structurally compromised during manipulations of the fixation device in the heart.
[0235] FIG. 18A through 18C illustrates an embodiment to assist visualization of fixation during the procedure. It is achieved via an optic camera with light source 800 embedded inside a balloon 802 filled with clear liquid such as saline or DI water. Alternatively, the in-situ camera and or the light source may be replaced with optic-fiber based scope.
[0236] FIG. 18B shows an example of embodiment wherein the balloon is inflated via the delivery catheter lumen, optical visualization is achieved along the surface of the transparent balloon. In this embodiment, a semi-compliant or variable stiffness balloon configuration may be used. During deployment, the balloon 802 is inflated with clear saline or DI water to contact the clip and/or tissue to provide visual feedback via the camera 800. Visual feedback can be used for planning and performing the procedure.
[0237] FIG. 18C show an example of a porous outer balloon 804 surrounding an non-porous interior balloon 806 surrounding the optic camera with light source 800 the porous outer balloon displaces ambient blood for improved visualization.
[0238] FIG. 18D shows the optic camera with light source 800 on a retractable/steerable structure inside of a balloon 808 with variable compliance. A high compliance inner surface 812 of the balloon conforms to the upper surfaces of the clips and leaflets to provide improved contact for increased visualization. The upper surface 812 of the balloon can be stiffer to assure full expansion of the balloon 810 over the clip and leaflets. The balloon 810 may be on the delivery catheter or implant or may be as a standalone device.
[0239] FIG. 18E shows a pair of optical cameras or fiber-optic sensors 820 housed within or on balloons 822 that are mounted on a retractable/steerable structure 824. Alternatively, these sensors/cameras may be mounted on a steerable/retractable shaft 826.
[0240] FIG. 19 shows one or more optical coherence tomography (OCT) sensors 830 attached to a distal shaft 832 of the delivery system. These sensors 830 may be mounted in multiples, or on a retractable and/or steerable shaft 834. This would allow for high-resolution tissue and delivery device imaging during implantation.
[0241] FIG. 20 shows one or more ultrasound sensors 840 attached to a distal shaft 842 of the delivery system. These sensors 840 may be mounted in multiples, or on a retractable and/or steerable shaft 844. This would allow for 2D, 3D, and Doppler modalities integrated to help navigate and perform the procedure.
[0242] Note that any combination of the embodiments illustrated in FIGS. 18A-E through 20 may be used as a part of this invention, to accomplish visualization. In a preferred embodiment, these visualization ideas disclosed should be sufficient to replace transesophageal echocardiogram (TEE) and or fluoroscopy. TEE is one of the primary reason for patient to undergo general anesthesia during the procedure. Hence, eliminating the requirement for TEE during the procedure reduces the risks associated with general anesthesia. While reducing fluoroscopy lowers the risks from x-rays.
[0243] Sensors and actuators that may be used in relation to this invention, to improve the safety, ease of use, and efficacy of the delivery system and fixation device. Sensors and actuators may be used to assist and evaluate device delivery (acute) and efficacy (acute or chronic). Sensors and actuators may be active or passive, removable or implantable and may provide acute or chronic physiological or non-physiological data to assess or evaluate patient health. Sensors and actuators may be active or passive, removable or implantable and provide acute or chronic physiological or non-physiological data to access or evaluate implant integrity and or function Sensors may be used for visualization: thermal, optical, ultrasonic (including ICE), OCT, fluoroscopic Sensors and actuators may be electrical, mechanical, magnetic, RF, chemical or combination. Sensors and actuators may be wired or wireless and may communicate with mobile or fixed external interface. The catheters of the present invention may be used as a conduit for external sensors, for example pressure sensor replacing Swan-Ganz catheter The term sensor and actuator may be used interchangeably. Sensors and actuators listed are for examples only. Any suitable metal or polymer or ceramic, organic or inorganic, flexible or rigid, matrix or material and their combinations may be used to produce the desired sensors and actuators.
[0244] All implant embodiments described in this invention may be optionally covered, wrapped, coated, or the like to improve biocompatibility and tissue interface. Suitable coverings can be fabric, web, fibrous, braid, woven or non-woven. The coatings can be metallic, ceramic, polymeric, or combinations thereof. Suitable metallic coatings include titanium, TiN, tantalum, gold, platinum, and alloys thereof. Suitable ceramic and inorganic coatings include titanium dioxide, hydroxyapatite, CaP, and the like. Suitable polymeric coatings include fluoropolymers, e.g. PTFE, PFA, FEP, ECTFE, ETFE; parylene, polyester, PET, polypropylene, PEEK, PVDF, HDPE, LDPE, UHMWPE, phosphorylcholine, THV, and the like. Suitable biodegradable include poly(lactic acid), poly(glycolic acid), polydioxanone, poly(c-caprolactone), polyanhydride, poly(ortho ester), copoly(ether-ester), polyamide, polylactone, poly(propylene fumarate), and their combinations. Such metallic, ceramic and/or polymeric coatings are listed as examples only. Any suitable metal, ceramic, polymer, and combination thereof may be used to produce a desirable coating.
[0245] The following is a listing of the reference numbers used in this application: [0246] 10 Base bracket, of the fixation device in the preferred embodiment. [0247] 11 Slanted section of base bracket 10 for enhanced ease of deployment [0248] 12 Outer arm, of the preferred embodiment used to capture leaflet. [0249] 14 Inner arm, of the preferred embodiment used to capture leaflet. [0250] 16 Release bar, the distal most component of the delivery catheter that interfaces with the fixation device. [0251] 17 Posts on Release bar 16 to enable spreading/lowering of the Outer Arms [0252] 18 Release rod; long rod running through delivery system that attaches Base bracket 10 of the fixation device to the Release bar 16; pulling the rod 18 releases and deploys the fixation device. [0253] 20 Outer arm, exemplary embodiment of a fixation device used to capture leaflet. [0254] 22 Inner arm, exemplary embodiment of a fixation device used to capture leaflet. [0255] 24 Fastener holding arms of fixation device to the Base bracket (10) in the preferred embodiment. [0256] 26 Feature of Release bar (16) allowing sutures to loop through and manipulate the arms of the fixation device. [0257] 28 A feature of Release bar 16 that attaches delivery catheter shaft 499. [0258] 30 Feature of Release bar (16) allowing sutures to loop through and manipulate the arms of the fixation device. [0259] 32 Feature of Release bar 16 allowing for passage of sutures [0260] 34 Feature of Release bar 16 allowing for passage of sutures [0261] 36 Feature of Release bar 16 allowing for passage of sutures [0262] 38 Feature of Release bar 16 allowing for passage of sutures [0263] 41 Segment of suture 47 [0264] 42 Segment of suture 47 [0265] 43 Segment of suture 48 [0266] 44 Segment of suture 48 [0267] 47 Suture allowing control of outer arm 12 [0268] 48 Suture allowing control of arm 20 [0269] 51 Manipulation of suture 47 [0270] 52 Manipulation of suture 48 [0271] 54 Gap between the Post 17 and Outer base 10 [0272] 57 Manipulation of Outer base 10 relative to Release bar 16 [0273] 60 Manipulation of outer arms [0274] 60 Barbs used in grabbing leaflet tissues in a particular embodiment [0275] 61 Manipulation of outer arms [0276] 62 Manipulation of inner arms [0277] 63 Manipulation of inner arms [0278] 64 Manipulation of inner arms [0279] 65 Manipulation of inner arms [0280] 71 Segment of suture 75 [0281] 72 Segment of suture 76 [0282] 73 Segment of suture 75 [0283] 74 Segment of suture 76 [0284] 75 Suture allowing control of inner arm 14 [0285] 76 Suture allowing control of inner arm 22 [0286] 77 Manipulation of suture 75; collapses inner arm 14 [0287] 78 Manipulation of suture 76; collapses inner arm 22 [0288] 82 Suture loop at end of inner arm 22 allowing for manipulation sutures to engage arm; unneeded if suture is run through the arm itself [0289] 83 Suture loop at end of inner arm 14 allowing for manipulation sutures to engage arm; unneeded if suture is run through the arm itself [0290] 91 Segment of suture 95 [0291] 92 Segment of suture 97 [0292] 93 Segment of suture 95 [0293] 94 Segment of suture 97 [0294] 95 Suture allowing control of arm 12 [0295] 96 Suture allowing control of sutures 95 and 97 [0296] 97 Suture allowing control of arm 20 [0297] 98 Suture loop used to constrain sutures 95 and 97 [0298] 101 Segment of suture 96 [0299] 102 Segment of suture 97 [0300] 103 Segment of suture 95 [0301] 110 Manipulation of suture segment 93 [0302] 111 Manipulation of suture segment 94 [0303] 112 Manipulation of suture segment 98 [0304] 120 Feature of release bar allowing for fastening of the fixation device through feature 130 [0305] 121 Embodiment of outer arm with shorter length [0306] 122 Embodiment of inner arm with shorter length [0307] 130 Protruding feature of bracket (24) allowing for the fastening of the fixation device to the release bar 16 using feature 120 [0308] 132 Outer arm in a particular embodiment [0309] 134 Inner arm in a particular embodiment [0310] 136 Outer arm in a particular embodiment [0311] 138 Inner arm in a particular embodiment [0312] 161 A feature of Release bar 16 that attaches delivery catheter shaft 499 in a retrograde embodiment [0313] 162 Feature of release bar (16) allowing for the fixation device to be secured to the delivery system through feature 130 in a retrograde embodiment [0314] 164 Feature of release bar (166) allowing sutures to loop through and manipulate the arms of the fixation device in a retrograde embodiment [0315] 166 Release bar, in retrograde configuration [0316] 168 Feature of release bar (166) allowing sutures to loop through and manipulate the arms of the fixation device in a retrograde embodiment [0317] 180 Manipulation of release rod (18) releasing the fixation device from the delivery system [0318] 201 Outer arm piece in a particular embodiment [0319] 202 Inner arm piece in a particular embodiment [0320] 203 Spacer providing gap for tissue capture between arms in a particular embodiment [0321] 204 Outer arm of a particular embodiment [0322] 400 Radiopaque marker(s) of Steerable Guide Catheter [0323] 401 Intermediate Steerable Guide shaft section allowing stiffness transition for 2-way and or 4-way steering [0324] 402 Distal Steerable Guide shaft section allowing for 2-way and or 4-way steering [0325] 403 Dilator [0326] 405 Proximal shaft of Steerable Guide Catheter [0327] 498 Shaft of Guide catheter [0328] 499 Shaft of Delivery catheter [0329] 500 Knob used alongside knob 501 to provide four-way steering to distal Delivery shaft (499) in a particular embodiment [0330] 501 Knob used alongside knob 500 to provide four-way steering to distal Delivery shaft (499) in a particular embodiment [0331] 502 Knob used to raise and lower inner/outer arms of fixation device [0332] 503 Knob used to raise and lower inner/outer arms of fixation device [0333] 504 Knob providing two-way steering to Delivery catheter distal shaft (499) in a particular embodiment [0334] 505 Knob providing two-way steering to distal steerable guide sheath (498) in a particular embodiment [0335] 508 Particular embodiment of a Delivery catheter handle holding knobs 502 and 503 [0336] 510 Particular embodiment of a steerable guide catheter handle holding knob 505 [0337] 511 Particular embodiment of a catheter handle holding knobs 502 and 503 [0338] 515 Particular embodiment of a Delivery catheter handle holding knobs 502, 503, and 518 [0339] 517 Particular embodiment of a Delivery catheter handle holding knobs 502, 503, 520, and 521 [0340] 518 Knob providing two-way steering to distal delivery shaft (499) in a particular embodiment [0341] 520 Knob used alongside 521 to provide four-way steering to distal delivery shaft (499) in a particular embodiment [0342] 521 Knob used alongside 520 to provide four-way steering to distal delivery shaft (499) in a particular embodiment [0343] 523 Particular embodiment of a steerable guide catheter handle holding knobs 528 and 529 [0344] 528 Knob used alongside 529 to provide four-way steering to steerable distal guide sheath (498) in a particular embodiment [0345] 529 Knob used alongside 528 to provide four-way steering to steerable distal guide sheath (498) in a particular embodiment [0346] 550 Quarter-turn locking Release rod 18 knob [0347] 615 Stainless steel sheath to support Delivery Handle [0348] 623 Stainless steel sheath to support Steerable Guide Handle [0349] 700 Etched markings used to indicate the function of various catheter knobs (e.g. 529) [0350] 702 Etched markings used to indicate the function of various catheter knobs (e.g. 528) [0351] 715 Delivery Catheter flush port [0352] 725 Steerable Guide Catheter flush port [0353] 727 Steerable Guide hemostasis valve lock [0354] 730 Quarter-turn locking Dilator 403 knob [0355] 735 Pinch lockable hemostasis valve on Steerable Guide [0356] 745 Exemplary embodiment of a custom steerable guide catheter handle, based on concept described in FIG. 2G [0357] 747 Exemplary embodiment of a custom delivery catheter handle, based on concept described in FIG. 2G [0358] 800 optic camera with light source [0359] 802 balloon filled with clear liquid [0360] 804 porous outer balloon [0361] 806 non-porous interior balloon [0362] 808 balloon with variable compliance [0363] 810 balloon over the clip and leaflets [0364] 812 upper surface of the balloon [0365] 820 optical camera or fiber-optic sensor [0366] 822 balloon [0367] 824 retractable/steerable structure [0368] 826 steerable/retractable shaft [0369] 830 optical coherence tomography sensors 8 attached to a [0370] 832 distal shaft [0371] 834 retractable and/or steerable shaft. [0372] 840 ultrasound sensors [0373] 842 distal shaft [0374] 844 retractable and/or steerable shaft [0375] LF Leaflet of mitral valve
[0376] Although many embodiments of the disclosure have been described in detail, certain variations and modifications will be apparent to those skilled in the art, including embodiments that do not provide all the features and benefits described herein. It will be understood by those skilled in the art that the present disclosure extends beyond the specifically disclosed embodiments to other alternative or additional embodiments and/or uses and obvious modifications and equivalents thereof. In addition, while a number of variations have been shown and described in varying detail, other modifications, which are within the scope of the present disclosure, will be readily apparent to those of skill in the art based upon this disclosure. It is also contemplated that various combinations or sub-combinations of the specific features and aspects of the embodiments may be made and still fall within the scope of the present disclosure. Accordingly, it should be understood that various features and aspects of the disclosed embodiments can be combined with or substituted for one another in order to form varying modes of the present disclosure. Thus, it is intended that the scope of the present disclosure herein disclosed should not be limited by the particular disclosed embodiments described above. For all of the embodiments described above, the steps of any methods need not be performed sequentially.
